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The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .

The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.

Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.

ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).

ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products.

The ALKO Reagents for the Olympus AU 800™/AU 5200™ Chemistry Systems are intended as direct replacements for Olympus reagents for the quantitative determination of Na+, K+, and Cl- concentrations in serum and urine by Ion Selective Electrodes (ISE).

1. Acceptance Criteria and Reported Device Performance:

The document describes two main types of studies to demonstrate equivalence: Precision Data and Correlation with Olympus Reagents.

Precision Data Acceptance Criteria (Implied):
While explicit acceptance criteria (e.g., maximum allowable CV%) are not stated, the reported precision data for ALKO reagents is expected to be within acceptable limits for clinical laboratory use and comparable to predicate device performance (Olympus reagents). The data shows Coefficient of Variation (CV%) values generally below 1.5% for all analytes across various serum and urine levels, indicating good precision.

Correlation with Olympus Reagents Acceptance Criteria (Implied):
For correlation studies, the acceptance criteria are generally based on:

• Slope: Close to 1.0 (indicating proportional agreement)
• Intercept: Close to 0.0 (indicating no systematic bias)
• R-squared (Correlation Coefficient Squared): Close to 1.0 (indicating strong linear correlation)

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Note: The "acceptance criteria" are implied based on common expectations for clinical chemistry assays and the reported values supporting substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Precision Test Set:

  • Serum: 3 levels of serum controls. Each level involved 48 measurements (duplicate per run, 4 runs per day for 5 days).
  • Urine: 2 levels of urine controls. Each level involved 48 measurements (duplicate per run, 4 runs per day for 5 days).
  • Data Provenance: Not explicitly stated, but assumed to be from a controlled laboratory setting. It is a prospective study as data was collected specifically for this filing.

• Correlation Test Set:

  • Serum: 40 serum samples and 9 serum controls (Total N=49).
  • Urine: 70 urine samples and 6 urine controls for Na+ and Cl- (Total N=76). 66 urine samples and 6 urine controls for K+ (Total N=72).
  • Data Provenance: Not explicitly stated, but assumed to be from a controlled laboratory setting. It is a prospective study as data was collected specifically for this filing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. This submission is for in vitro diagnostic reagents on an automated chemistry analyzer, not for image-based diagnostic devices requiring expert interpretation. The "ground truth" for the test samples would be the values obtained by the established reference method (Olympus reagents) or highly controlled, traceable values for the controls.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not an expert-based diagnostic assessment, no adjudication method like 2+1 or 3+1 is relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• Not Applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, in spirit. The performance studies (precision and correlation) represent the standalone performance of the ALKO reagents when used on the Olympus system. The results reported are direct measurements from the analyzer using ALKO reagents, with comparison to results obtained using Olympus reagents. There is no human interpretation or intervention in the measurement process itself that would constitute a "human-in-the-loop."

7. The Type of Ground Truth Used:

• Comparative Reference Method: For the correlation study, the "ground truth" for the test samples was the analytical results obtained using the Olympus reagents on the same Olympus AU800 analyzer. This establishes equivalence by comparing ALKO reagents to the predicate device's performance.
• Known Control Values: For the precision study, commercially available serum and urine controls with established target ranges were used. The mean values obtained are compared against potentially expected values for these controls.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a set of chemical reagents for an existing automated analyzer, not a machine learning or AI algorithm that requires a training set. The "training" of the system would involve calibration with the provided standards according to the manufacturer's instructions.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set in the AI sense, this question is not relevant. The "ground truth" for the calibrators (standards) used to set up the assay would be based on their certified values, often traceable to reference materials or methods. The document mentions "The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module," implying these calibrators have established values.

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